Balance; DistortedNCT03307265
Impact of the Use of a Weighted Jacket on the Balance of Patients With a Balance Disorder.
A study testing Personalized weighted jacket in people with Balance; Distorted, run by Bernard Dachy at 1 site in Belgium.
Trial summary
The aim of the study is to test whether wearing a weighted jacket can help improve the balance distortion of patients with neurologic pathologies. The center of mass of the patient will be analyzed in order to determine the direction in which the imbalance is most important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Balance; Distorted
- What is being tested?
- Personalized weighted jacket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Sep 2017to 27 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good level of French understanding
- be able to walk a minimum distance of 10 meters with or without rod/walker
- walk 10 meters in more than 12 seconds.
- have a diagnosis of Multiple Sclerosis, Parkinson's, or any other neurological pathology that could cause balance disorders
- be able to endure at least 2 hours of tests, interviews or medical care.
- score of more than 8 seconds at the time up and go (TUG), less than 24 points out of 28 in the Tinetti test
Who cannot join
- the patient underwent a period of exacerbation of his pathology in the last two months (especially for multiple sclerosis patients)
- chronic back pain
- poor eyesight (not be able to perform the tests)
- osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Use of a Weighted Jacket on the Balance (While Walking or Standing) of Patients With a Balance Disorder.
The aim of the study is to test whether wearing a weighted jacket can help improve the balance distortion of patients with neurologic pathologies.
The center of mass of the patient will be analyzed in order to determine the direction in which the imbalance is most important. Weights will be placed accordingly in a jacket in order to correct the imbalance. In the experimental group, weights will represent 1.5 to 2% of the patient body mass. In the control group, the investigators will use weights of 200 grams maximum, placed evenly on both sides of the jacket. Patients will wear the jacket for 2 consecutive hours.
Read more
After wearing the jacket for 2 hours, data similar to those recorded at the beginning of the experiment will be taken again, namely the determination of the center of mass and of the deviations caused by the imbalance.
A final series of tests will take place approximately one week after wearing the jacket, to determine if there are any residual effects.
- Conditions
- Balance; Distorted
- Being tested
- Personalized weighted jacket, Control jacket
- Keywords
- Weighted Jacket, Balance disorder, Equilibrium disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized weighted jacketDevice
Patients in this group will wear a jacket with weights (1,5 to 2% of the total body mass) strategically placed in order to correct their imbalance.
Control jacketDevice
Patients in this group will wear a jacket with weights (200 grams maximum) evenly distributed.
| Study group | Role | What they receive |
|---|---|---|
| Imbalance correction | Experimental | Not described Receives: Device: Personalized weighted jacket |
| Control | Active comparator | Not described Receives: Device: Control jacket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imbalance
The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.
Measured: Data measured after 2 hours of jacket utilisation
Time Up and Go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: Data measured after 2 hours of jacket utilisation
Tinetti test
The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
Measured: Data measured after 2 hours of jacket utilisation
Berg balance scale
The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
Measured: Data measured after 2 hours of jacket utilisation
Secondary outcomes (4)
Imbalance
The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.
Measured: 1 week after jacket utilisation
Time Up and Go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: 1 week after jacket utilisation
Tinetti test
The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
Measured: 1 week after jacket utilisation
Berg balance scale
The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
Measured: 1 week after jacket utilisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start12 Sep 2017
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance; DistortedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernard Dachy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bernard Dachy, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307265
- Sponsor's protocol ID
- CHUB-Weighted jacket
- Status last verified
- Jul 2018
- First submitted
- 6 Oct 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of a Weighted Jacket on the Balance (While Walking or Standing) of Patients With a Balance Disorder.
- ClinicalTrials.gov ID
- NCT03307265
- Acronym / sponsor ID
- CHUB-Weighted jacket
- Conditions
- Balance; Distorted
- Keywords
- Weighted Jacket, Balance disorder, Equilibrium disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bernard DachyUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to test whether wearing a weighted jacket can help improve the balance distortion of patients with neurologic pathologies.
The center of mass of the patient will be analyzed in order to determine the direction in which the imbalance is most important. Weights will be placed accordingly in a jacket in order to correct the imbalance. In the experimental group, weights will represent 1.5 to 2% of the patient body mass. In the control group, the investigators will use weights of 200 grams maximum, placed evenly on both sides of the jacket. Patients will wear the jacket for 2 consecutive hours.
After wearing the jacket for 2 hours, data similar to those recorded at the beginning of the experiment will be taken again, namely the determination of the center of mass and of the deviations caused by the imbalance.
A final series of tests will take place approximately one week after wearing the jacket, to determine if there are any residual effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imbalance correction | Experimental | Device: Personalized weighted jacket |
| Control | Active comparator | Device: Control jacket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- good level of French understanding
- be able to walk a minimum distance of 10 meters with or without rod/walker
- walk 10 meters in more than 12 seconds.
- have a diagnosis of Multiple Sclerosis, Parkinson's, or any other neurological pathology that could cause balance disorders
- be able to endure at least 2 hours of tests, interviews or medical care.
Key exclusion criteria (4 listed)
- the patient underwent a period of exacerbation of his pathology in the last two months (especially for multiple sclerosis patients)
- chronic back pain
- poor eyesight (not be able to perform the tests)
- osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized weighted jacketPatients in this group will wear a jacket with weights (1,5 to 2% of the total body mass) strategically placed in order to correct their imbalance. | Device | Imbalance correction |
| Control jacketPatients in this group will wear a jacket with weights (200 grams maximum) evenly distributed. | Device | Control |
Primary outcome
Imbalance
Time frame: Data measured after 2 hours of jacket utilisation
The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.
Time Up and Go
Time frame: Data measured after 2 hours of jacket utilisation
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Tinetti test
Time frame: Data measured after 2 hours of jacket utilisation
The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
Berg balance scale
Time frame: Data measured after 2 hours of jacket utilisation
The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
4 secondary outcomes
Imbalance
Time frame: 1 week after jacket utilisation
Time Up and Go
Time frame: 1 week after jacket utilisation
Tinetti test
Time frame: 1 week after jacket utilisation
Berg balance scale
Time frame: 1 week after jacket utilisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized weighted jacket in people with Balance; Distorted, run by Bernard Dachy at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imbalance (time frame: Data measured after 2 hours of jacket utilisation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.